Senior Mfg/ops Quality Engineer

1 week ago

Woodlands, Singapore Illumina Full time

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:
This role is responsible to ensure that design transfer and manufacturing operations activities are executed in compliance with Illumina’s established Quality Management System (QMS) and relevant international/national regulations. These activities include, but are not limited to, validation, non-conformance, customer complaints, risk assessment and support maintenance of the QMS.

Position Responsibilities:
- Serve as Quality representative on project teams for new product transfers- Review and approve manufacturing operational activities, such as Device History Records (DHR), nonconformance, CAPA, RMA, and customer complaints- Work with cross-functional teams to resolve operational quality issues- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary- Ensure the quality systems meet customer, corporate, or internal requirements and any other related requirement within the Quality Management System- Participate in management of corrective action program (customer complaints) to ensure timely follow-up, completion and documentation of corrective actions- Manage customer complaints and work closely with cross function in issue investigation and ensure timely response of to corporate/ customer- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits- Other such duties that may be determined by Supervisor
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities._

Position Requirements:
- Bachelor’s degree in Engineering or Biological/Life Sciences or equivalent field- Minimum 5 years of experience in a medical device manufacturing environment.- Excellent interpersonal, verbal and written communication skills-
- Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus- Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis- Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools- Proficient in computer systems such as Microsoft Office & SAP- Experience with statistical analysis packages, e.g. JMP, Minitab is highly preferred

  • Senior Manager, Supplier Quality

    6 days ago

    Woodlands, Singapore SCIEX Full time

    As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve...

  • Senior Design Quality Engineer

    6 days ago

    Woodlands, Singapore Illumina Full time

    What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases...

  • Engineer Quality

    6 days ago

    Woodlands, Singapore GLOBALFOUNDRIES Full time

    **About GLOBALFOUNDRIES** **Manufacturing Quality System Management and Improvement**: - Facilitation for Change management/ NC material disposition system. - Ensure compliance according documented quality systems - Customer specific requirement (CuSR) execution and compliance enforcement - Participation continuous improvement activities to improve...

  • Quality Assurance Engineer

    1 week ago

    Woodlands, Singapore Schott Singapore Pte Ltd. Full time $80,000 - $120,000 per year

    Quality Management System :Implement, maintain, and continuously improve the organization's ISO 9001 and IATF 16949 Quality Management Systems to ensure compliance and drive quality excellence.Develop and deliver quality-related training programs tailored for all employee levels to foster awareness and adherence to quality standards.Plan, execute, and...

  • Quality Engineer

    6 days ago

    Woodlands, Singapore APPLIED TOTAL CONTROL TREATMENT PTE LTD Full time

    **Responsibilities**: - Perform review/gap analysis on customer’s specifications for chemical processes, with adequate process control measures. - To conduct quarterly internal audits to ensure process compliance according to plating specifications - Actively involve in new process setup, buy-off and qualification program - Involve in quality issues...

  • Mts Mfg Technical Training

    4 days ago

    Woodlands, Singapore GLOBALFOUNDRIES Full time

    **About GLOBALFOUNDRIES **GLOBALFOUNDRIES is a leading full-service semiconductor foundry providing a unique** **combination of design, development, and fabrication services to some of the world’s most inspired technology companies. With a global manufacturing footprint spanning three continents, GLOBALFOUNDRIES makes possible the technologies and systems...

  • Quality Assurance Specialist

    2 weeks ago

    Woodlands, Singapore RexAdvance Technology Pte Ltd Full time $60,000 - $180,000 per year

    As a Quality Assurance Specialist, you will champion quality standards and process integrity across machining and surface treatment operations. You will develop and implement quality systems, conduct internal audit inspections, and ensure compliance with customer and industry standards. This role is critical in strengthening customer trust by preventing...

  • Quality Assurance Specialist

    1 week ago

    Woodlands, Singapore Rexadvance Technology Pte. Ltd. Full time $60,000 - $120,000 per year

    About the RoleAs a Quality Assurance Specialist, you will champion quality standards and process integrity across machining and surface treatment operations. You will develop and implement quality systems, conduct internal audit inspections, and ensure compliance with customer and industry standards. This role is critical in strengthening customer trust by...

  • Customer Quality Assurance Engineer

    1 week ago

    Woodlands, Singapore Private Advertiser Full time $60,000 - $120,000 per year

    Responsibility1.  Customer Complaint Management:Handle customer complaints, feedback, and ensure prompt responses.Maintain positive and effective communication with customers to address and resolve issues.2.  Problem Solving and Reporting:Analyze customer claims and lead problem-solving (8D) teams within the factory.Prepare and submit comprehensive 8D...

  • Senior Engineer, Equipment Engineering

    6 days ago

    Woodlands, Singapore GLOBALFOUNDRIES Full time

    **Introduction** We are expanding our Fab Operations and are looking for Equipment Engineers, In this role you will plan and implement effective preventive maintenance programs, monitor and control equipment performance indices and involve in various continuous improvement programs to drive optimization efforts across the organization.